PROPHY ANGLE— 510(k) K953628

Substantially Equivalent

Rolence Enterprise Co. , Ltd.

FDA 510(k) clearance K953628 for PROPHY ANGLE, Substantially Equivalent on 1995-09-29. Applicant: Rolence Enterprise Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Rolence Enterprise Co. , Ltd.
Product code: Code EHK
Device class: Class 1
Regulation: 21 CFR 872.6290
Advisory panel: Dental
Date received: 1995-07-31
Decision date: 1995-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungli, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.